Full service provider for protocol registration and results posting on ClinicalTrials.gov and EudraCT

Case Study

Partnering Clinical Trial Disclosure2018-06-26T08:02:33+00:00

Project Description

The challenge

A top-20 pharmaceutical company needed to outsource project management and protocol maintenance updates, in addition to regular updates of protocol and results postings.

The departure of a manager at the client site had left a gap in their project management support.

The newly appointed US Manager lacked prior experience in CTD and needed to prepare for upcoming EU disclosure requirements.

“The Kinapse team have consistently delivered high quality documents and commitment to customer service. We are very happy with the level of support and the value Kinapse provides!”
– Clinical Trial Disclosure Lead, Top 20 Pharma

Our approach

Our experienced Project Lead and Senior Medical Writer guaranteed seamless project management support for our client. We also established an oversight manager on-site, and remotely, to streamline the project.

Additionally, we established a 1-month-interim medical writer for on-site support with the EU disclosure along. The interim writer was also there to provide advisory support.

The team lead supported and educated the new US Manager, helping her to get accustomed to her new responsibilities in this sector.

The result

The client has remained a long-term partner since July 2009. In that time, we have established a dedicated team of writers and oversight management support from India.

Since then, we’ve completed over 150 protocol registrations.

Based on the quality of that work, the scope of the project has been extended to include protocol updates and results postings. So far, we’ve completed more than 50.

The project has also been extended to include maintenance updates of protocol and project management support. This allows client’s team to focus on critical activities.

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